LONDON, Oct. 12, 2017 /PRNewswire/ -- INTRODUCTION
A number of monoclonal antibodies (more than 70) have already been approved for use in humans. These therapeutic products, which target a particular epitope on an antigen, have become a popular and robust treatment option for various diseases. However, despite the success of antibody therapeutics, there are several limitations associated with the use of mono-specific antibodies. It has been reported that certain patients treated using these therapeutic modalities have failed to respond, or have developed resistance to the therapy.
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Moreover, since the development and progression of several diseases, such as cancer, are dependent on the cross-talk between multiple signaling pathways, molecules directed against a single target may not elicit the desired therapeutic effect.
Bispecific antibodies have demonstrated the capability to address the existing challenges associated with monoclonal antibodies, such as high manufacturing costs, limited applicability in assays and the general lack of understanding of precise in vivo mechanisms of action. Although the concept of bispecific antibodies was conceived more than five decades ago, this field has gained significant popularity in recent years.
These molecules have the potential to be used across a broad range of application areas; for example, they can be used to redirect effector cells, simultaneously modulate more than one signaling pathway, and deliver toxic payloads to target sites in a more specific manner. It is also important to highlight that advances in molecular cloning technologies, coupled with a better understanding of antibody engineering techniques, have led to the discovery and development of a number of different bispecific antibody formats, setting them up for use across novel application areas as well.
SCOPE OF THE REPORT
The â€˜Bispecific Antibody Therapeutics Market (3rd Edition), 2017-2030â€™ report provides a comprehensive study of the current landscape of bispecific antibodies, featuring an elaborate discussion on the future potential of this upcoming market. The field has captured the interest of several drug developers, including both small and large companies. As indicated before, the applicability of these engineered biomolecules is vast.
Presently, only one bispecific antibody, BLINCYTOÂ® (2014), is available for therapeutic use. However, the development pipeline of bispecific antibody based drugs has several promising candidates that are likely to result in commercial success stories in the foreseen future. The overall pipeline comprises of over 200 molecules that are under development for the treatment of various disease indications across different therapeutic areas, including oncology, autoimmune disorders and infectious diseases. Of these, more than 60 molecules are currently under clinical evaluation, while over 140 product candidates are in the discovery / preclinical stages.
The evolving market has its hopes pinned on multiple start-ups, small and large-sized companies, which are engaged in this domain.
Amongst other elements, the report features:
â€¢ A review of the current market landscape, featuring a detailed analysis based on target disease indications / patient segments, phases of development of product candidates (clinical and preclinical / discovery), bispecific antibody formats (fragment based bispecific antibodies, asymmetric bispecific antibodies and symmetric bispecific antibodies), routes of administration (intravenous, subcutaneous, and intravitreal) and mechanisms of action (dual targeting, T-cell engagement, NK-cell engagement, half-life extension and bispecific antibody drug conjugate).
â€¢ Comprehensive profiles of marketed and clinical stage (phase II and above) bispecific antibody therapeutics, highlighting their current status of development, clinical trial information and trial results, and a brief overview, financial performance (if available), and an informed future outlook of the developer.
â€¢ An analysis of the partnerships that have been inked between stakeholders in the industry in the recent past, covering research collaborations, licensing agreements, product development / commercialization agreements, manufacturing agreements, mergers / acquisitions, product development agreements, clinical trial collaboration and other deals.
â€¢ A grid analysis, representing the distribution of the pipeline of bispecific antibodies (on the basis of mechanisms of action of product candidates and antibody formats) across different therapeutic areas and stages of development.
â€¢ A bubble analysis comparing the available technology platforms on the basis of important parameters, such as clinical activity (based on the number of drug candidates developed using a particular technology), number of partnerships established and the size of the developer company.
â€¢ A spider-web analysis highlighting the popularity of different mechanisms of action of bispecific antibody candidates. The analysis takes into consideration various parameters, such as number of bispecific antibodies, number of ongoing clinical trials, target therapeutic indications, number of publications and the companies that are developing these molecules.
â€¢ An elaborate discussion on a lifecycle management strategy, depicting how companies are using indication expansion as a tool to expand their foothold in the field of bispecific antibody therapeutics.
â€¢ A case study on the key promotional strategies adopted for marketing the approved bispecific antibody, BLINCYTOÂ®, and other competitive molecules that have been recently approved for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia.
One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target patient population, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2017-2030.
The research, analysis and insights presented in this report include potential sales of bispecific antibody therapeutics that are currently marketed or are in the late stages of development. To account for the uncertainties associated with the development of novel bispecific antibody therapeutics and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the marketâ€™s evolution.
The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The study includes detailed transcripts of discussions held with Jane Dancer (CBO, F-star), Ludge Gro•e-Hovest (Founder and CSO, Synimmune), Siobhan Pomeroy (Senior Director, Business Development, CytomX Therapeutics) and Yinjue Wang (Associate Director, Process Development, Innovent Biologics). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
â€¢ Annual reports
â€¢ Investor presentations
â€¢ SEC filings
â€¢ Industry databases
â€¢ News releases from company websites
â€¢ Government policy documents
â€¢ Industry analystsâ€™ views
While the focus has been on forecasting the market over the coming 10-15 years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
Chapter 2 provides an executive summary of the insights captured during our research. It offers a high level view on the likely evolution of the bispecific antibody therapeutics market in the mid to long term.
Chapter 3 provides a general overview of antibodies covering their historical background, structure, and the types of antibodies available, along with their mechanisms of action. In addition, the chapter highlights the evolution of antibody based therapeutics over the last few years. It also features a discussion on bispecific antibodies, elaborating on the different bispecific formats that are currently available, mechanisms of action of various products / product candidates and their applications.
Chapter 4 includes information on over 200 bispecific antibody therapeutics that are currently in different stages of development. It features a comprehensive analysis of the pipeline molecules, highlighting the target therapeutic areas, phases of development, antibody formats, routes of administration and the corresponding mechanisms of action.
Chapter 5 provides a list of technologies that are either currently available, or being developed by various firms, for the generation of bispecific antibody therapeutics. In addition, it features detailed profiles of some of the key technologies that have been used to develop at least four clinical and / or preclinical bispecific antibody candidates. Each profile contains details on the technology, such as the structure of bispecific antibody, pipeline molecules developed using the technology, its advantages and partnerships established related to the technology.
Chapter 6 contains detailed profiles of drugs that are in advanced stages of clinical development (phase II, filed and marketed). Each profile provides information on the mechanism of action, current status of development, dosage form and treatment regimen, information on clinical studies and key clinical trial results of the drug. It also includes an overview of the developer, its financial details and an informed future outlook.
Chapter 7 presents a comprehensive market forecast analysis, highlighting the future potential of the market till the year 2030. It includes future sales projections of bispecific antibody therapeutics that are either marketed or are in advanced stages of clinical development (phase II and preregistration). The sales potential and growth opportunity were estimated based on the target patient population, likely adoption rates, existing / future competition from other drug classes and the likely price of products. The chapter also presents a detailed market segmentation on the basis of key therapeutic areas (oncology, autoimmune disorders, inflammatory disorders, eye disorders and others) and mechanisms of action (T-cell engagement, NK-cell engagement, dual targeting, blocking cytokines and others).
Chapter 8 features an elaborate discussion and analysis of the various collaborations and partnerships that have been inked amongst players in this market. We have also discussed the different partnership models and the most common forms of deals / agreements that have been established between 2012 and 2017.
Chapter 9 is a compilation of key insights derived from the study. It presents a detailed logo landscape of the companies engaged in developing bispecific antibody based products, distributed based on the developmental status of pipeline candidates and size of the companies (small, mid-sized and large companies). The chapter also features a grid analysis, representing the distribution of bispecific antibody candidates (on the basis of their mechanisms of action and formats) across target therapeutic areas and stages of development. It also features a comparative study, presented in the form of a bubble analysis, of the different platforms that are being utilized for the generation of bispecific antibodies. The parameters considered for this analysis include the development activity based on the technology (in terms of the number of drugs across different phases of development), number of partnerships established related to the technology and the size of the developer company. Additionally, the chapter features a spider-web analysis, which highlights the activity of bispecific antibodies based on their mechanisms of action. The parameters considered for this analysis include number of drug candidates, active clinical trials, publications, target indications and the companies that are involved in this domain.
Chapter 10 includes a detailed discussion on product life cycle management strategies. It primarily focuses on the indication expansion strategy, which is being used extensively by the developers of bispecific antibody based therapeutics.
Chapter 11 highlights the key promotional strategies that are being implemented by the developer (Amgen) of the marketed bispecific antibody, BLINCYTOÂ® (approved for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia). For the purpose of this analysis, we also studied the promotional activities of two other drugs, namely IclusigÂ® and MarqiboÂ®, which are approved for the treatment of the same indication. The promotional aspects covered in the chapter include details provided on the product website (covering key messages for patients and healthcare professionals), patient support offerings and informative downloadable content, and product visibility in scientific conferences.
Chapter 12 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of the bispecific antibodies market within the biopharmaceutical industry, under a comprehensive SWOT framework.
Chapter 13 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.
Chapter 14 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. The chapter provides details of interviews held with Jane Dancer (CBO, F-star), Ludge Gro•e-Hovest (Founder and CSO, Synimmune), Siobhan Pomeroy (Senior Director, Business Development, CytomX Therapeutics) and Yinjue Wang (Associate Director, Process Development, Innovent Biologics).
Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures included in the report.
Chapter 16 is an appendix, which provides the list of companies and organizations mentioned in the report.
1. Close to 68% of bispecific antibody based therapeutic products are in the early stages of development (preclinical / discovery), while one bispecific antibody therapeutic (BLINCYTOÂ®) is approved for the treatment of acute lymphoblastic leukemia. 11 products are in advanced clinical evaluation (phase II and above); these include (in alphabetical order) ABT-981 (AbbVie), AFM13 (Affimed), Anti-CD3 MUC1 bispecific antibody (Benhealth Biopharmaceutical), emicizumab (Chugai Pharmaceutical), HER2Bi-Armed Activated T Cells (Barbara Ann Karmanos Cancer Institute), istiratumab (Merrimack Pharmaceuticals), MEDI3902 (MedImmune), ozoralizumab (Ablynx), RG7716 (Roche), SAR156597 (Sanofi) and vobarilizumab (Ablynx).
2. The market landscape is well distributed across small (33), large (30) and mid-sized (25) companies. Some of the prominent small-sized companies engaged in this domain include (in alphabetical order) Affimed, Avillion, Amphivena Therapeutics, Benhealth Biopharmaceutical, EngeneIC and Oxis Biotech. In addition, well established companies, such as (in alphabetical order) Amgen, AstraZeneca, Boehringer Ingelheim, Bayer, Emergent BioSolutions, Merck, Pfizer, Roche and Sanofi, are also actively involved in this domain. It is worth mentioning that several universities / research organizations have also contributed to the development of bispecific antibody therapeutics; examples include (in alphabetical order), Barbara Ann Karmanos Cancer Institute, California Institute for Biomedical Research, Duke NeuroSurgery, Fraunhofer Institute of Molecular Biology and Applied Ecology, Sun Yat-Sen University, The First Affiliated Hospital with Nanjing Medical University, The Scripps Research Institute and Vanderbilt Vaccine Center.
3. Bispecific antibodies are capable of simultaneously targeting more than one target and are, therefore, capable of treating clinical conditions that are characterized by cross-talk between multiple disease related pathways. Currently, almost 80% of the development programs are focused on oncological indications, including hematological cancers and solid tumors. Apart from oncology, autoimmune disorders are the most popular; close to 9% of candidate drugs in the pipeline are being developed for such clinical conditions. It is also worth highlighting that the bispecific antibody products are being developed for other therapeutic areas, such as infectious diseases, blood disorders and eye disorders.
4. The market features the presence of a diverse range of bispecific antibody generation platforms, which is indicative of the ongoing innovation in this domain. During our research, we identified around 50 unique platforms that have been developed / are being developed for the generation of different bispecific antibody therapeutics. Of these, we observed that 11 technology platforms are being extensively used; these include (in alphabetical order) Dual Affinity Re-targeting (DART) (MacroGenics), Bispecific T-cell Engager (BiTE) (Amgen), CrossMAb (Roche) and Nanobody (Ablynx)
5. Close to 100 partnerships were inked between various stakeholders in the industry during the period between 2012 and July 2017. Of these, approximately 43% were early R&D related deals; recent examples include Ablynx and Sanofi (July 2017), Numab and Kaken Pharmaceutical (June 2017), and Merus and Institute for Research in Biomedicine, Barcelona (January 2017). Other popular types of collaborations were product / technology licensing agreements (23%), product development and commercialization agreements (16%), manufacturing agreements (4%) and merger / acquisitions (4%). Some of the acquisitions that we came across include Celgene Corporation and EngMab (October 2016), and Aduro Biotech and BioNovion (September 2015).
6. Our future market outlook is highly optimistic as we expect several new drugs to be approved and launched over the coming decade. Examples of drugs in late stages of development include emicizumab, ABT-981, SAR156597, vobarilizumab, istiratumab, AFM13, MEDI3902 and RG7716. In fact, by 2030, we expect the market to grow at an annualized rate of ~34%. Specifically, we believe that emicizumab, istriatumab, ABT-981 and AFM13 will attain blockbuster status and become prime contributors to the marketâ€™s revenue.
7. Majority of product candidates are T-cell engagers; molecules using this particular mechanism of action are estimated to capture 58% share of the market by 2023. However, in the long term (by 2030), molecules belonging to other product classes having different mechanisms of action, such as blocking cytokines, dual targeting, and half-life extension, are collectively projected to capture almost 75% of the market.
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